Commission Delegated Regulation (EU) 2016/161Show full title

Article 4 Composition of the unique identifier

The manufacturer shall place on the packaging of a medicinal product a unique identifier which complies with the following technical specifications:

(a)

The unique identifier shall be a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product.

(b)

The unique identifier shall consist of the following data elements:

(i)

a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product bearing the unique identifier (‘product code’);

(ii)

a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomisation algorithm (‘serial number’);

(iii)

a national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market;

(iv)

the batch number;

(v)

the expiry date.

(c)

The probability that the serial number can be guessed shall be negligible and in any case lower than one in ten thousand.

(d)

The character sequence resulting from the combination of the product code and the serial number shall be unique to a given pack of a medicinal product until at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.

(e)

Where the national reimbursement number or other national number identifying the medicinal product is contained in the product code, it is not required to be repeated within the unique identifier.